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Freedom Wrist Arthroplasty System

Model 348294E · Smith & Nephew, Inc. · DI 00885556856048

JWJ — Prosthesis, Wrist, 3 Part Metal-Plastic-Metal Articulation, Semi-Constrained · Class II · 21 CFR 888.3800

UDILibrary device dossier · generated 2026-09-12 · sources: FDA GUDID, openFDA (recalls, MAUDE, 510(k)/PMA), FDA Data Dashboard (inspections, compliance actions), 510(k) summary documents.

Recall history (0)

No recalls linked in the loaded window.

Adverse-event reports — MAUDE (0)

Caveat (required reading): MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line is a reporting baseline (average device in the same product code), not a risk measure.

11222019-07: 0 reports for this device; peer average 1/device2019-09: 0 reports for this device; peer average 1/device2019-11: 0 reports for this device; peer average 1/device2021-02: 0 reports for this device; peer average 1/device2021-09: 0 reports for this device; peer average 1/device2022-05: 0 reports for this device; peer average 1.5/device2022-11: 0 reports for this device; peer average 1.5/device2022-12: 0 reports for this device; peer average 2/device2023-10: 0 reports for this device; peer average 1/device2023-11: 0 reports for this device; peer average 1/device2023-12: 0 reports for this device; peer average 1/device2024-01: 0 reports for this device; peer average 1/device2024-10: 0 reports for this device; peer average 1/device2025-02: 0 reports for this device; peer average 1/device2025-05: 0 reports for this device; peer average 1/device2025-06: 0 reports for this device; peer average 2/device2025-09: 0 reports for this device; peer average 1/device2026-05: 0 reports for this device; peer average 1/device070911020905111210111201100205060905
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0701
2019-0901
2019-1101
2021-0201
2021-0901
2022-0501.5
2022-1101.5
2022-1202
2023-1001
2023-1101
2023-1201
2024-0101
2024-1001
2025-0201
2025-0501
2025-0602
2025-0901
2026-0501
This device (reports/month)Average device in JWJ (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Predicate lineage

K132250 — cites (transitively): K030037 (d1), K042032 (d1) — cited as predicate by K191525

Lineage extracted from public 510(k) summary text (heuristic).

Manufacturer compliance record — Smith & Nephew, Inc.

  • Warning Letter 2015-04-30 Smith & Nephew Inc.
  • Warning Letter 2015-04-30 Smith & Nephew Inc.
  • Warning Letter 2014-06-11 Smith & Nephew, Inc.
  • Warning Letter 2010-09-16 Ascension Orthopedics, Inc
  • NAI 2025-01-27 Integrity Orthopaedics Inc · 0 citations
  • NAI 2023-05-03 CARTIHEAL, LTD · 0 citations
  • VAI 2021-12-09 Smith & Nephew, Inc. · 1 citations
  • VAI 2021-12-09 Smith & Nephew, Inc. · 1 citations
  • NAI 2021-10-26 Smith & Nephew Inc. · 0 citations
  • NAI 2021-10-26 Smith & Nephew Inc. · 0 citations
  • VAI 2020-02-06 Blue Belt Technologies, Inc · 6 citations
  • NAI 2019-10-25 Tusker Medical, Inc. · 0 citations
  • VAI 2019-10-08 Tusker Medical, Inc. · 3 citations
  • NAI 2018-03-30 Ascension Orthopedics, Inc · 0 citations
  • NAI 2018-02-02 Smith & Nephew, Inc. · 0 citations
  • NAI 2018-02-02 Smith & Nephew, Inc. · 0 citations
  • NAI 2018-01-30 Smith & Nephew · 0 citations
  • NAI 2017-08-21 Smith & Nephew, Inc. Advanced Surgical Devices Division · 0 citations
  • VAI 2017-08-02 Smith & Nephew, Inc. · 3 citations
  • VAI 2017-08-02 Smith & Nephew, Inc. · 3 citations
  • NAI 2017-07-24 Smith & Nephew, Inc. · 0 citations
  • NAI 2017-07-24 Smith & Nephew, Inc. · 0 citations
  • NAI 2017-05-25 Smith & Nephew, Inc. · 0 citations
  • NAI 2017-05-25 Smith & Nephew, Inc. · 0 citations